Drug alert class 4: paracetamol infusion, accord. (mdr 07-02/19)


Drug alert class 4: paracetamol infusion, accord. (mdr 07-02/19)

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DRUG ALERT CLASS 4: PARACETAMOL INFUSION, ACCORD. (MDR 07-02/19) Accord Healthcare Limited has informed us that there is an error on the portion of the Patient Information Leaflet (PIL) for


the Paracetamol Infusion which is intended for Healthcare Professionals. PRODUCT DESCRIPTION Paracetamol 10mg/ml Solution for Infusion MAH HOLDERS Actavis Group PTC ehf, PL 30306/0391 Accord


Healthcare Limited, PL 20075/0701 BRIEF DESCRIPTION OF THE PROBLEM Accord Healthcare Limited has informed us that there is an error on the portion of the Patient Information Leaflet (PIL)


for the above product which is intended for Healthcare Professionals. The PIL for Paracetamol 10mg/ml Solution for Infusion is a joint PIL between the 50ml vial and the 100ml vial. The error


applies to the 50ml vial, which is not currently marketed. The 100ml vial is restricted for use in adults, adolescents and children weighing more than 33kg but we cannot rule out the


possibility that it is being used for the treatment of term newborn infants, infants, toddlers and children weighing 33kg or less. All unexpired batches of the product currently on the


market supplied by both Marketing Authorisation holders listed above are within scope. In the incorrect version of the PIL, the maximum volume of solution for administration to babies and


infants weighing 10kg or less is given as 75ml on the dosage table intended for Healthcare professionals. The correct maximum volume for administration to this group is 7.5ml, however. The


PIL has already been corrected and can be accessed here. Distribution of affected batches will cease once corrected stock is available. It is anticipated that new batches will be available


during Q2 2019. CONTACT INFORMATION For stock control enquiries, please contact Accord Customer Services Team on 0800 373573 For medical Information enquiries, please contact Accord Medical


Information Department on 01271 385257 ADVICE FOR HEALTHCARE PROFESSIONALS Advice for healthcare professionals Recipients of this Drug Alert should bring it to the attention of relevant


contacts by copy of this letter. DOWNLOAD DOCUMENT Drug Alert Class 4, Paracetamol Infusion, Accord. UPDATES TO THIS PAGE Published 28 February 2019